Bortezomib in Combination With CC-5013 in Patients With Relapsed/Refractory Multiple Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00153933|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Refractory Multiple Myeloma Relapsed Multiple Myeloma Multiple Myeloma||Drug: Bortezomib Drug: CC-5013||Phase 1|
- Within 21 days of starting treatment the following tests will be performed: physical exam (including vital signs), ECG, neurological examination, blood tests, urine tests, bone marrow aspiration, x-rays and MRI or CT scan.
- Patients will receive bortezomib intravenously on day 1,4,8 and 11 followed by 10 days of rest. CC-5013 will be given orally on days 1-14 followed by 7-dyas of rest. One cycle lasts 21 days. This study will evaluate different dose levels of bortezomib and CC-5013 to see which dose level seems to be the best for most people. There will be 8 dose levels.
- Patients will be assigned to a dose level depending upon when they begin the study and how other dose levels have been tolerated by patients that are already on the study. Three to six patients will be treated at each dose level and will be observed for one full cycle. Depending upon the side effects, the dose level will increase, stay the same or be decreased by one level for the next group. 10 additional patients will be treated at the dose that is thought the best.
- On day four of the treatment cycle blood tests, vital signs and a review of side effects will be performed.
- On day eight of the the treatment cycle blood tests, vital signs, review of side effects and an ECG will be performed prior to medication administration. A bortezomib level will be taken before bortezomib infusion, 15 minutes, 1/2 hour, 45 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours and 12 hours after the dose. Additional blood levels will be collected 24, 48, and 72 hours after the dose. (These blood levels will done during the first cycle only).
- On day 11 and day 14 of the treatment cycle blood tests, vital signs and review of side effects will be performed.
- After 2 cycles of treatment, the doctor will assess how the patient's disease is responding to the treatment. Additional tests such as bone marrow biopsy, x-rays or scans may be performed. If the disease is stable or getting better, patients will continue to receive repeated cycles of treatment. If the disease is getting worse, dexamethasone may be added to the treatment cycle.
- If dexamethasone is added, the dosing will start on days 1,2,4,5,8,9 and 11 of the 21-day cycle. The disease will then be reassessed after 2 additional cycles. If the disease is getting worse, the patient will be removed from the study.
- Once 8 cycles of treatment have been performed, the disease will be fully assessed again by blood tests, bone marrow biopsy, x-rays or scans. Again, if it is determined that the disease is stable of getting better, additional treatment cycles can be performed. If the disease is getting worse, treatment will be stopped..
- A follow-up visit will be scheduled one month after the last dose of the study drug and will include: physical exam, vital signs, neurological examination, and review of symptoms.
- Patients will remain on this study as long as the side effects are not too severe and the disease has not progressed.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Phase I Study of the Safety and Efficacy of Bortezomib in Combination With CC-5013 in the Treatment of Subjects With Relapsed and Relapsed/Refractory Multiple Myeloma|
|Study Start Date :||August 2004|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Experimental: CC-5013 in combination with bortezomib
Participants will receive bortezomib intravenously on day 1,4,8 and 11 followed by 10 days of rest. CC-5013 will be given orally on days 1-14 followed by 7-days of rest. One cycle lasts 21 days.
Given intravenously on days 1, 2, 8, 11 of each 21-day cycle. Participants can remain on study treatment as long as their disease doesn't worsen and they don't experience any serious side effects.
Other Name: velcade
Orally on days 1-14 of each 21-day cycle. Participants can remain on study treatment as long as their disease doesn't worsen and they don't experience any serious side effects.
- To evaluate the safety of bortezomib when given in combination with CC-5013 in subjects with relapsed and relapsed/refractory multiple myeloma, to identify the MTD as well as a RP2D. [ Time Frame: 2 years ]
- To evaluate the response of the combination of bortezomib and CC-5013
- To determine the pharmacokinetics of bortezomib and CC5013 in patients with multiple myeloma. [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00153933
|United States, Florida|
|H. Lee Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|United States, Georgia|
|Winship Cancer Center|
|Atlanta, Georgia, United States, 30322|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02115|
|Dana-Farber Cancer Center|
|Boston, Massachusetts, United States, 02115|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, New York|
|St. Vincent's Comprehensive Cancer Center|
|New York City, New York, United States, 10011|
|Principal Investigator:||Paul Richardson, MD||Dana-Farber Cancer Institute|